Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Pediatric labeling milestone

Executive Summary

FDA's approval of new labeling for Novartis' seizure therapy Trileptal addressing its use in children and teenagers marks the 100th product to add pediatric information to its label since the implementation of the FDA Modernization Act in 1997, the agency announces Dec. 19. "This is a highly gratifying achievement for our most precious patients, their parents, and their physicians," Acting FDA Commissioner Andrew von Eschenbach said. Since FDAMA was enacted, manufacturers have conducted more than 250 pediatric studies for 125 products compared to only 11 such studies in the seven years prior to the legislation. FDAMA, along with the 2002 Best Pharmaceuticals for Children Act, provide sponsors incentives for conducting pediatric trials (1"The Pink Sheet" May 14, 2001, p. 21)...

You may also be interested in...



Pediatric Labeling Negotiations Limited To 6 Months In Reauthorization Bill

Negotiations for pediatric labeling changes would be limited to six months under a proposed bill to reauthorize the pediatric exclusivity provisions.

Amneal Eyes Avastin And Praises $120m Biosimilar Development Savings

Amneal is close to a filed pipeline of three biosimilar products in the US, while furthering ambitions in the complex generics and 505(b)(2) space, management told the virtual J.P. Morgan Healthcare Conference.

Zydus Cadila Testing Three-Dose COVID-19 Vaccine

Zydus Cadila is to begin testing a three-dose recombinant DNA vaccine candidate in Phase III Indian trials, which might enter late-stage development ahead of Inovio and AnGes. The company promised to provide 100-150 million doses by end of 2021 at the J.P. Morgan Conference, though adherence could be a roadblock.

UsernamePublicRestriction

Register

OM007016

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel